ACCUTIP COVER

Tonometer, Manual

ACCUTOME, INC.

The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Accutip Cover.

Pre-market Notification Details

Device IDK132549
510k NumberK132549
Device Name:ACCUTIP COVER
ClassificationTonometer, Manual
Applicant ACCUTOME, INC. 3222 PHOENIXVILLE PIKE Malvern,  PA  19355
ContactAdam Pickholtz
CorrespondentAdam Pickholtz
ACCUTOME, INC. 3222 PHOENIXVILLE PIKE Malvern,  PA  19355
Product CodeHKY  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-14
Decision Date2014-04-23
Summary:summary

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